Status:
UNKNOWN
Post Market Clinical Follow-up Study for Arthroplasty Shoulder System of FX Solutions at the Long Term
Lead Sponsor:
FX Solutions
Conditions:
Shoulder Disease
Shoulder Fractures
Eligibility:
All Genders
18+ years
Brief Summary
This study takes place in the framework of the Post-Market Clinical Follow-up of the FX Solutions Shoulder System. The goal of this PMCF study is to collect clinical data in order to confirm the safet...
Detailed Description
Inclusion Criteria * Adult patient (≥ 18 years old) who received one of FX Solutions Shoulder System for indication of hemi or total shoulder replacement. * Patient implanted between 2011 and 2015 wi...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- First of all, in order to be eligible to the study protocol, patients should have been treated primarily with one of studied device depending on surgeons' strategies' cares.
- In order to be eligible to participate in this study, patients must meet all of the following criteria:
- Adult patient (≥ 18 years old) who received one of FX Solutions Shoulder System for indication of hemi or total shoulder replacement.
- Patient implanted between 2011 and 2015 with a minimum follow-up of 7 years
- Patient has been informed of his participation in a clinical study and did not object to data collection
- Patient insured with a social security system
- Exclusion criteria for subject selection.
- Patient who does not meet the inclusion criteria above
- Protected adult
- People deprived of their liberty
Exclusion
Key Trial Info
Start Date :
April 7 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
416 Patients enrolled
Trial Details
Trial ID
NCT05284357
Start Date
April 7 2022
End Date
October 1 2022
Last Update
August 12 2022
Active Locations (20)
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1
Hôpital Privé Antony
Antony, France, 92160
2
CHU Jean MINJOZ
Besançon, France, 25000
3
Centre hospitalier Bourg en Bresse
Bourg-en-Bresse, France, 01000
4
Clinique Convert
Bourg-en-Bresse, France, 01000